Recall Z-0978-2025
Integra LifeSciences Corp. · initiated December 16, 2024
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
CODMAN CERTAS Plus Programmable Valve Inline Small Valve Only. Model Number: 828810PL. Implantable device that provides constant intraventricular pressure and drainage of CSF for the management of hydrocephalus.
Codes / lots: UDI-DI: 10381780535881. Lot Numbers: 7416790, 7432471, 7434929, 7434930, 7438312 and 7438313.
Reason for recall
Potential for certain SKUs and lot numbers were distributed with the incorrect product description on the internal and external labels.
FDA-determined cause: Labeling Change Control
Action taken
Integra LifeSciences notified consignees on about 12/16/2024 via letter. Consignees were instructed to review and understand the information provided in the letter, complete and return the provided Customer Acknowledgement Form, remove any affected units from service and quarantine them, arrange for return of affected units, and forward the notification to anyone who utilizes the affected units. Distributors were instructed to follow the same directions but also requested to notify any customers if product was further distributed, and return affected units.
Details
- Recall number
- Z-0978-2025
- Initiated
- December 16, 2024
- Posted by FDA
- January 17, 2025
- Product code
- JXG – Shunt, Central Nervous System And Components
- Quantity
- 170 units
- Distribution
- US Nationwide distribution in the states of FL, NC, MA, MN, OH, DC, VA, CA, WI, NE, TX, NY, MI, OR, NJ, SC, AZ, UT, RI, IN, GA, CO and the countries of Canada, Australia, New Zealand, Cyprus, Sweden, Finland, Slovenia and Great Britain.
- Recalling firm
- Integra LifeSciences Corp., Princeton, NJ
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0977-2025 Class II | CODMAN CERTAS Plus Programmable Valve Inline Small Valve Only. Model Number: 828810…Potential for certain SKUs and lot numbers were distributed with the incorrect product description on the… | 12/16/2024Open, Classified |
| Z-0979-2025 Class II | CODMAN CERTAS Plus Programmable Valve Right Angle Valve Only. Model Number: 828820.…Potential for certain SKUs and lot numbers were distributed with the incorrect product description on the… | 12/16/2024Open, Classified |